FDA•MODERATE
Zeiss Intrabeam Spherical Applicator
Zeiss is recalling the 1.5 cm Intrabeam Spherical Applicator (REF 304534-6000-557) due to failure to meet manufacturing specifications.
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Medical Devices Recalls
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FDA•MODERATESiemens ARTIS icono Ceiling SuspensionSiemens is recalling the ARTIS icono ceiling suspension (Model 11328100) because monitor attachment screws may loosen over time.
FDA•CRITICALDSAEK Pack-RX Surgical Convenience KitDSAEK Pack-RX kits recalled due to contaminated alcohol prep pads; stop use and contact firm.
4 products
FDA•MODERATERayCare 2024A SP1 Oncology Information SystemsRaySearch recalls RayCare 2024A SP1 oncology software due to potential data loss in beam set delivery notes.
2 products
FDA•CRITICALHillrom Volara System Patient Circuit KitBaxter recalls Hillrom Volara P.CIRCUIT KIT (REF M08085) due to nebulizer cup leakage causing oxygen drop and ineffective treatment.
4 products- Device RecallFDA•MODERATEMedela ENFit Enteral Extension Set
Medela is recalling ENFit Enteral Extension Sets due to incorrect connectors that may cause delivery delays or misconnections.
FDA•MODERATEAccuray Cyberknife Xchange Robotic Collimator ChangerAccuray is recalling the Xchange Robotic Collimator Changer for the Cyberknife system due to a risk of the collimator falling from its housing.
FDA•MODERATEARTIS icono biplaneSiemens recalls ARTIS icono biplane over potential loss of movement after detector lift height adjustment.
3 products
FDA•MODERATEAccuray Cyberknife Xchange Robotic Collimator ChangerAccuray is recalling the Cyberknife Xchange Robotic Collimator Changer due to a risk of the component falling from its housing.
FDA•MODERATECRE Pro Wireguided DilatorBoston Scientific recalls CRE Pro Wireguided dilator due to potential sterile pouch breach.
12 products
FDA•MODERATEIntelliCuff Portable Cuff Pressure ControllerThe IntelliCuff pressure controller may fail to maintain cuff pressure due to a system leakage error, causing the motor to run continuously.
FDA•MODERATEPilling Wecksorb NeurospongesTeleflex is recalling Pilling Wecksorb Neurosponges and Neurosponge Strips due to potential out-of-specification levels of endotoxins.
2 products
FDA•MODERATEBaxter Adapter for Head PositioningBaxter is recalling the Adapter for Head Positioning due to a risk of the accessory becoming loose and moving during patient positioning.
FDA•MODERATERemel GC Agar BaseRemel is recalling GC Agar Base plates due to a risk of reduced or no recovery of Neisseria gonorrhoeae strains.
FDA•CRITICALHamilton Medical Ventilator Coaxial Breathing CircuitHamilton Medical is recalling ventilator coaxial breathing circuits due to a risk of valve membrane adhesion and inadequate ventilation.
FDA•MODERATEMedline Convenience Kits with LidocaineMedline recalls 3 convenience kits with Huons Lidocaine ampules due to quality issues.
19 products
FDA•MODERATEMedacta Shoulder System Short Monobloc Stem BroachesMedacta is recalling Short Monobloc Stem Broaches for the Shoulder System due to a risk of humerus fracture during surgery.
FDA•MODERATEMedline Convenience Kits with Swan-Ganz CathetersMedline recalls convenience kits with BD Swan-Ganz catheters due to hub failure risk.
9 products
FDA•MODERATEMentor Luer Lok 10cc SyringesMentor is recalling a lot of 10cc Luer Lok syringes that were distributed after their expiration date.
FDA•MODERATEIntera 3000 Hepatic Artery Infusion PumpIntera 3000 Hepatic Artery Infusion Pump recalled over potential drug pathway leakage.
FDA•MODERATEMedline Convenience Kits with 10mL Polycarbonate SyringesMedline recalls convenience kits with 10mL polycarbonate syringes due to unapproved design changes.
23 products
FDA•CRITICALAbiomed Impella CP Introducer KitAbiomed recalls Impella CP introducer kit (14 Fr x 13 cm) over thrombus risk.
4 products
FDA•MODERATEPhilips Telemetry Monitor 5500Philips is recalling Telemetry Monitor 5500 units due to a potential reset error that prevents connection to the central monitoring system.
- Device RecallFDA•MODERATEThuvera Laser Console
IPG Medical is recalling the Thuvera Laser Console due to a software anomaly that may cause a false error code 5018 display.
FDA•CRITICALMedline CV Anesthesia Room Setup KitsMedline recalls CV Anesthesia Room Setup kits due to quality issues with included lidocaine and bupivacaine injections.
5 products
FDA•MODERATEGE Healthcare AW Server 3.2 ext.6.5GE Healthcare is recalling the AW Server 3.2 ext.6.5 image processing system due to a software error that may display the wrong patient's data.
FDA•MODERATEOctopus Evolution Tissue StabilizerMedtronic recalls Octopus Evolution Tissue Stabilizer TS2000 due to incorrect tubing assembly.
3 products
FDA•MODERATESurgify Halo BurrSurgify Halo 3.0 mm burr recalled due to potential breakage during spinal surgery.
19 products
FDA•MODERATEStryker InZone Detachment SystemStryker is recalling the InZone Detachment System due to premature battery drain that may prevent coil detachment during medical procedures.
FDA•MODERATEAcumed Hexalobe ScrewsAcumed is recalling various hexalobe screws used in wrist fixation systems due to a risk of the screws breaking during use.
2 products
FDA•MODERATEZimmer Off-Axis Reamer GuideZimmer recalls Off-Axis Reamer Guide (Model 110040240) due to breakage risk from catching during reaming.
5 products
FDA•MODERATEPFM Medical Multi-Snare SetPFM Medical is recalling Multi-Snare Set catheter devices due to a failure to meet biocompatibility requirements for in-vitro cytotoxicity.
FDA•MODERATEVentec VOCSN+Pro Respiratory SystemVentec is recalling the VOCSN+Pro respiratory system because a damaged battery may prevent the backup alarm from sounding during power loss.
FDA•MODERATEPhilips Avalon Fetal Monitor FM20Philips recalls Avalon Fetal Monitor FM20 over speaker connector issue that may cause loss of speaker output.
2 products
FDA•MODERATEDa Vinci Surgical System E-Brake Retainer PinIntuitive Surgical is recalling the Da Vinci surgical system E-brake retainer pin due to a risk of uncontrolled motion and patient injury.
FDA•MODERATETMJ Bilateral ImplantsTMJ Solutions is recalling custom temporomandibular joint implants due to incorrect components causing a poor fit and potential open bite.
- Device RecallFDA•MODERATEHeartMate 3 LVAS Backup Battery
Thoratec recalls HeartMate 3 LVAS kits (model 106524US) due to 11V backup battery failures.
6 products 
FDA•MODERATEInspire Respiratory Sensing LeadInspire is recalling its Respiratory Sensing Lead (Model 4340) due to incorrect Use By Dates that may lead to premature revision surgery.
3 products
FDA•CRITICALImpella CP Set with SmartAssistAbiomed is recalling Impella CP Sets with SmartAssist due to a risk of low purge pressure that may interrupt mechanical circulatory support.
FDA•MODERATEBD Connecta Luer-Lok StopcockBD is recalling Connecta Luer-Lok stopcocks due to a potential connection failure at Port C when using plastic luer-lok syringes.
FDA•MODERATESplashwire Hydrophilic Guide WireMerit Medical is recalling various Splashwire Hydrophilic Guide Wire models due to unsealed pouches that may compromise device sterility.
2 products
FDA•MODERATETriathlon Universal Baseplate Size 3/4Stryker recalls Triathlon Universal Baseplates due to size mislabeling in packaging.
2 products
FDA•MODERATEMedline Red Rubber Latex Urethral CathetersMedline recalls Red Rubber Latex Urethral Catheters (REF DYND13508–DYND13522, DYND13614/16) over surface, connector, and diameter defects.
34 products
FDA•MODERATEGiraffe OmniBed Canopy SoffitGE HealthCare recalls Giraffe OmniBed incubator/warmer over canopy soffit fastener risk that could injure patients.
3 products
FDA•MODERATEConMed AirSeal 5 mm Access PortConMed recalls AirSeal 5 mm Access Port (iASB5-150) over overpressure alert risk.
11 products- Device RecallFDA•MODERATESTAAR ICL Calculation Software
Staar Surgical is recalling Version 8.00 of its ICL Calculation Software due to a coding error affecting toric lens orientation diagrams.
2 products 
FDA•MODERATEdirectCHECK ACT-LR Whole Blood Quality ControlAccriva Diagnostics is recalling directCHECK ACT-LR whole blood quality control, level 2, due to incorrect performance range labeling.
FDA•MODERATEMedtronic O-arm O2 Imaging SystemMedtronic is recalling the O-arm O2 Imaging System due to a firmware anomaly that may cause image artifacts during clinical use.
FDA•MODERATEHarmonyAIR A-Series Surgical Lighting SystemHarmonyAIR A-Series surgical lights recalled: intensity buttons may detach.
2 products
FDA•MODERATEHarmonyAIR A-Series Surgical Lighting SystemSteris is recalling HarmonyAIR A-Series Surgical Lighting Systems due to a risk of paint delamination on the light heads.